NCT00318838 is a Phase 1 clinical trial of Azimilide dihydrochloride in Healthy, sponsored by Forest Laboratories.

Who is sponsoring NCT00318838?

NCT00318838 is sponsored by Forest Laboratories.

What drugs are being tested in NCT00318838?

Interventions in NCT00318838: Azimilide dihydrochloride, Placebo.

Is NCT00318838 still recruiting?

NCT00318838 is currently completed. Last updated 31 January 2017.

Last reviewed 2017-01-31 · How we verify

NCT00318838

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Double-blind, Randomized, Parallel-group, Placebo-controlled, Multiple-dose Study to Assess the Effect of 125 mg/Day Orally Administered Azimilide Dihydrochloride on Renal Function and Hemodynamics in Healthy Volunteers

Completed Phase 1 Last updated 31 January 2017

What this trial tests

Phase 1 trial testing Azimilide dihydrochloride in Healthy in 21 participants. Completed in 1 May 2006.

Timeline

1 April 2006

Primary endpoint
1 May 2006

1 May 2006

Quick facts

Lead sponsor	Forest Laboratories
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	21
Start date	1 April 2006
Primary completion	1 May 2006
Estimated completion	1 May 2006
Sites	1 location across United States

Drugs / interventions tested

Azimilide dihydrochloride — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Forest Laboratories — full company profile →

Who can join

Adults 18 to 45, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

To assess the effect of multiple dosing of 125 mg azimilide on glomerular filtration rate and total creatinine clearance in healthy subjects
Time frame: 6 days

Sponsor's own description

This study will assess the effect of multiple dosing of 125 mg azimilide on glomerular filtration rate (GFR) and total creatinine clearance (GFR + active secretion) in healthy subjects. Also, it will assess the effect of multiple dosing of 125 mg azimilide on renal hemodynamics (RPF) in healthy subjects.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Forest Laboratories trials

Trials by the same sponsor.

NCT02788617 — Evaluation of the Efficacy of Diafert in Predicting Embryos' Potential to Develop to the Blastocyst Stage · completed
NCT02732327 — Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer · Phase 2 · terminated
NCT02670538 — Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode · Phase 3 · completed
NCT02670551 — Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depres · Phase 3 · completed
NCT02559570 — A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 6-17 Years Who Fulfill · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00318838 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Forest Laboratories
Last refreshed: 31 January 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00318838.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing